Monthly Archives: April 2019

//April

Commercializing Industrial Biotechnology 2019 – May 13-14, 2019 in Los Angeles, CA

Biobased production of industrial chemicals, fuels, and specialties (industrial biotech) has had many triumphant moments in the last few decades.  Along with these successes, however, industrial biotech has also faced and had to overcome challenges, disappointments, and delays.  We seem now to be at a turning point where regulatory and environmental factors, customer and consumer [...]

2019-04-30T19:08:39+00:00April 30th, 2019|

Webinar: Introduction to FDA MyStudies App – May 9, 2019, 10 am to 3 pm ET

The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries. This event will demonstrate the capabilities of the system [...]

2019-04-24T17:55:54+00:00April 24th, 2019|

12th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference – April 24-25, 2019 in Washington, DC

This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. This conference allows attendees to take a deeper dive into either therapeutic device or diagnostics topics. The two day conference will include topic table discussions and a poster session. Keynote Speaker Confirmed: [...]

2019-04-19T14:41:46+00:00April 19th, 2019|

Seminar – Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) – New Orleans, LA – May 2-3, 2019

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be [...]

2019-04-17T20:06:54+00:00April 17th, 2019|

Process Validation Requirements and Industry Practice Course – April 16-18, 2019 in Arlington, VA

This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation [...]

2019-04-12T20:27:56+00:00April 12th, 2019|